Obese patients can have increased morbidity from excess weight. Extra weight can place strain on body circulatory systems, respiratory systems, the digestive system, and can stress or overload body organs. This can cause numerous medical conditions such as diabetes, high blood pressure, high cholesterol, sleep apnea, and can increase the risk of a major coronary event. Bariatric medicine is focussed on the prevention, control, and treatment of obesity. Diet, drugs, and surgery are the most common tools used to reduce a patient's calloric intake, reduce their weight, and save their lives.
Bariatric surgical techniques can result in dramatic weight loss for the morbidly obese and can add years to a patient's life. These surgeries can include stomach stapling to create a small pouch, intestinal bypass surgery, gastric banding, placement of a large filler object in the stomach to reduce the internal volume of stomach, and gastric sleeves.
The small intestine is attached to the pyloric valve at the base of the stomach. The pyloric valve regulates the passage of partially digested food from the stomach and into the first portion of the small intestine. The first foot and a half to two feet of the small intestine absorbs the majority of the nutrients from the partially digested food as it passes through. Intestinal bypass surgery is focussed on bypassing this section of the intestine with surgical cutting and stapling procedures such as a Roux-en-Y.
Malabsorptive surgical procedures block the absorption of nutrients or block the flow of nutrients to the blood stream. These procedures can require less radical surgery than a bypass, and can include implantable devices such as a gastric sleeve that is attached to the stomach or intestinal wall near the pyloric valve. The gastric sleeve extends down into the upper section of the small intestine and places a barrier between the partially digested food and the duodenum or nutrient absorbing section of the small intestine. This barrier reduces the amount of nutrients absorbed by the body and results in weight loss. U.S. Pat. No. 7,037,344 by Kagan et al. teaches a gastric sleeve apparatus, methods of attachment to the body, and methods of use in the treatment of morbid obesity.
As an alternate to gastric sleeves, other barrier materials or techniques could be used. For example, a fluid, or a semi-fluid (gel) could be used as a barrier if it could be restrained in position to block nutrient absorption. The fluid or semi-fluid barrier material could undergo a phase change such as from a liquid to a solid or to a semi-solid. Monomer and polymer adhesives such as the cyanoacrylates are initially fluid, adhere well to tissue, and can create a barrier to nutrient absorption in the intestines. Closure Medical has developed a 2-octyl cyanoacrylate compound with a long carbon chain (eight carbons) that is biocompatible, has good bonding strength, and has received FDA approval for topical use. Additional FDA clinical trials are underway to use cyanoacrylate adhesives for internal surgical use. These adhesives can be biocompatible, rigid or flexible, and biodegradable or non-biodegradable inside the body.
Consequently, a significant need exists for an effective barrier that can block nutrient intake to achieve weight loss in a patient, be easy to apply, can be placed with a minimally invasive procedure such as placement through in a natural body orifice, minimize patient recovery time, and result in lower surgical costs.